Fierce Topline is brought to you by IQVIA Biotech. Built for biotech innovators, IQVIA Biotech is a full-service CRO designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com. Today is Friday, July 10th, and you're listening to The Top Line, brought to you by Fierce Pharma and Fierce Biotech. I'm your host, Ayla Ellison. this week we're starting with some of the big news across biopharma including vertex's 10 billion dollar acquisition of crinetics pharmaceuticals and growing scrutiny from u.s lawmakers over the industry's use of clinical trials in china then we'll turn to one of the biggest scientific meetings of the summer, the American Diabetes Association's scientific sessions. For years, ADA has been focused heavily on diabetes. That is, of course, still central to the meeting, but this year's conference in New Orleans made clear how much the conversation is evolving. Obesity data took up a lot of the spotlight, with GLP-1s and next-generation and incretin drugs continuing to push metabolic health into the center of the industry's attention. Later in the episode, Fierce Pharma senior editor Frazier Kansteiner will join Fierce Pharma marketing Zoe Becker to talk through what stood out at ADA. They'll cover the biggest data sets, what it was like to sit down with Novo Nordis' new CEO, and yes, Insulet's Marvel collaboration on a line of comics. Let's get into it. The first story I want to talk about comes from Fierce Pharma senior writer Kevin Dunleavy. Kevin covered Vertex's $10 billion deal to buy Crynetics. This is a big one for a few reasons. First, it's Vertex's largest acquisition to date. And second, it gives Vertex an approved endocrine disease drug in Pelsonify. And third, the deal brings in an investigational treatment for congenital adrenal hyperplasia that has also shown potential in Cushing syndrome. For Vertex, this is about expanding beyond its historic strength in cystic fibrosis. The company has been working for years to build out a broader portfolio, including in pain, sickle cell disease, and diabetes. With Crynetics, Vertex is making a major bet in rare endocrine diseases through a company that already has a commercial product, a late-stage pipeline, and a projected multi-billion dollar peak sales opportunity. The deal also fits into a broader theme we've been watching across biopharma. Companies with strong balance sheets are looking for assets that can create growth beyond their core franchises. In this case, Vertex is buying a foothold in an arena where it clearly sees room to grow. The second story comes from fierce biotech staff writer Will Maddox, who looked at the growing scrutiny around clinical trials conducted in China. This is a really important one because it goes beyond any single company. Over the past several years, China has become increasingly important to the global biopharma industry, both as a source of new drug candidates and as a place where companies conduct clinical development. We've also seen more U.S. and multinational drug makers license assets from Chinese biotechs or use data generated in China as part of their development strategies. Now, lawmakers are taking a closer look at that ecosystem. The concern is about where trials are conducted, data integrity, national security, patient protections and the extent to which U.S. drug development has become intertwined with China. For the industry, that creates uncertainty. If the regulatory or political environment changes, companies could face added costs, delays, or new questions about how data from China will be viewed. And for drug makers that have built China into their clinical or deal-making strategies, this could become a complication. So those are the two stories we're watching this week. Vertex making a major move into rare endocrine disease through its crinetics acquisition and U.S. lawmakers putting more pressure on a key part of the global clinical trial landscape. Now let's turn to the ADA. The annual meeting has long been one of the biggest gatherings for diabetes research, but this year's conference showed just how much the field is being reshaped by the obesity and metabolic health boom. Fierce Pharma senior editor Frazier Kansteiner was in New Orleans for the meeting, and he joined Fierce Pharma marketing Zoe Becker to break down the data, the biggest storylines, and the conversations that stood out on the ground. Here they are. So, Fraser, you have long served as our resident GLP-1 expert here at Fierce. You've been covering these obesity products pretty closely since their rollout, and recently you got to really jump into it at the American Diabetes Conference in New Orleans So before we get into some of the many many headlines you produced from the event how was it overall And can you confirm that you did in fact survive the New Orleans heat in June Yeah, no, I mean, it was a lot of fun. And in a lot of ways, it did kind of feel like a culmination of a lot of the coverage we've done recently on GLP-1s. Initially, kind of looking at sort of the really swift upper trajectory of medications like Ozempic and type 2 diabetes. And then Obviously, with originally Novo's Wagovi approval on obesity, things kind of kicked off to a pretty wild degree. And we've just been continuing to sort of chase that story ever since. I do really question the wisdom of having a medical conference, especially one that's bringing in a lot of people from Denmark to New Orleans in June. It was very, very warm. I even bought a special summer jacket to try to deal with the heat, but I don't know if that really solved the problem. There were a lot of people who were sopping wet and stopping in corners to kind of regroup after having to move around. But everything was pretty centrally located, so it was nice. But yeah, overall, I would say it was really fun, really busy, and really kind of a testament to the fact that this conference is what we need to be covering. And I'm sure our readers are going to be really interested in going forward. Well, that's good to hear. And I know you were also marked safe from being escorted out of the conference, which was one of the bigger non-data news pieces that happened at the event when some researchers were removed from the event due to like an editorial protest. But you didn't see any of that directly, did you? Yeah, I'm sad to say that I was not physically present when this happened. I was, I think, getting prepared for something else or maybe talking to someone at a hotel nearby. But on the first day of the conference, which it was like a weekend conference, so it started on a Friday in early June, there had been a couple of members who were essentially protesting against Trump administration cuts to national institutes of health funding, research grants, things like that. And these people were sort of dramatically escorted out of the conference center. I think police were involved. Again, I was not here personally to see that happen. I only heard about it afterward, but it definitely seemed like it was something that was on the mind of conference attendees pretty much the whole time. Almost any moment that I heard people kind of just having casual conversations in and around the conference, they were mentioning this. It was very easy to tell when people who had taken off their badges and were at restaurants or what else were from ADA because many people were discussing this. And then even that was a conversation taking place across from me at the airport terminal right before I left was people who'd been there who were kind of just aghast at these people being ejected. I will note, as we were kind of discussing this, that it does appear that the American Diabetes Association and their CEO apologized for this publicly, I think pretty quickly after it happened. But yeah, definitely a weird situation and kind of an odd tone to start the proceedings. Yeah, definitely. That's certainly one way to kick off this conference. But by the end of the conference, analysts ultimately declared Eli Lilly the clear winner of the weekend. Of course, they had a lot of data there to read out what some of their data that you reported on or that we reported on that they may have drawn this conclusion from. Yeah. So, I mean, really, it's rather unsurprisingly all about Reditrutide or Ritatrutide. Some Lilly executives told me that maybe we were saying it wrong, but it seems that is an issue of debate within Eli Lilly itself. But this is their triple G candidate being trialed both in obesity and diabetes. So we've seen quite a bit of data on this asset so far. It's sort of the next kind of flagship metabolic medicine from Eli Lilly and one that really is kind of expected to take some of the benefits that we've seen with ZepBound, their trisepatide obesity medication to the next level. Kind of the headline news here was that at the highest dose, 12 milligrams of retitrutide, The drug was linked to 28.3% average weight loss after 80 weeks of treatment if patients adhered to treatment as instructed. That is a really significant number that really does kind of eclipse a lot of what we have been seeing from other candidates. One of the other key points here and something that is going to become relevant as we sort of look at other companies reporting at the conference as well is Lily had two nested basket studies that it presented as well. And this was looking specifically at retitrutide in patients with osteoarthritis pain and moderate to severe obstructive sleep apnea. So kind of the point here is that especially as more and more big name companies and other developers are getting some of these new metabolic medicines toward the end of development, there really is this focus on not looking at weight loss alone and really kind of looking at the other health benefits and comorbidities that these medications can address. All of that kind of goes toward addressing obesity holistically as a chronic illness. And again, not just this aesthetic thing that's a result of lifestyle choices. You know, if we really quickly just want to run through some of that. And in the Triumph 1 study in patients with knee osteoarthritis, retrotide helped patients chart a 4.3 point or 73.1% reduction on the Western Ontario and McMaster University's osteoarthritis index. also known as the WOMAC pain subscale from a baseline of six. And then if we're looking at the moderate to severe obstructive sleep apnea population, Lily's triple agonist helps get patients down to 36.1 events per hour from a baseline of 58.6 events per hour on the apnea index. I had spoken to Rachel Batterham. She's Lily's SVP of medical innovation and external engagement about some of this. And her perspective was really interesting because she had spent 25 years treating patients with diabetes and obesity as a practicing clinician. So she was good at kind of helping contextualize what some of these results maybe mean for patients. And I think she talked about the fact that when she was seeing obesity patients, when they were talking about the things they were struggling with the biggest thing to them was not just the weight itself but physical functioning and in particular severe osteoarthritis She likened that 70 reduction on the WOMAG pain scale to 70% less pain every time a patient takes a step, adding that that would help people maybe get out and go to work and just be able to enjoy their lives more as well. This also held true what we're thinking about the sleep apnea data as well. And then of course, I think something really key here is the weight loss that we're seeing as well is just really significant. It's kind of hard not to see Lilly as leading the pack as they already kind of have been doing on the commercial front, at least in the US when we're comparing them to folks like Novo. But yeah, just really impressive data out of Red or Drew Tide. Absolutely. I mean, I can definitely see why that asset is getting a lot of hype. But of course, the event highlighted a lot more than just our main players here and Eli Lilly and Nobu Nordisk. For one, Amgen is looking to make its own case as the potential global leader in the management of cardiometabolic risk by 2030, which is what their chief medical officer, Paul Burney, told you. So what's Amgen's case here? Yeah, Amgen's an interesting story because they have another pretty high profile obesity and diabetes candidate in Maritide. And this was not actually what they were presenting on this year. They actually were talking about Repatha, but I got a lot of good context, I think. And I also spoke to Susan Sweeney, their EVP of obesity and related conditions, sort of about how the obesity and metabolic medicine market is shaping up and kind of how this opens the door for additional therapies beyond those first generation GLP-1s and dual agonists that we've seen from Novo and Lilly. So I think a big thing with Meritide, if we're looking at Amgen's candidate is they're looking at both improved tolerability, which is a major factor when we're thinking about these obesity medications. And then also, as Sweeney was pointing out and something we've reported on, Amgen is aiming for much, much less frequent dosing with this. So that potentially tackles two pretty key problems that currently affect the presently approved GLP-1s. Namely, first of all, these medications, it's a well-known fact, they have pretty unpleasant gastrointestinal side effects. Usually this is nothing unsafe, but it in practice means you're feeling nauseous. You may be throwing up, constipated, just kind of unpleasant and kind of cutting down the side effect is a big deal for developers of next-gen medicines. And this kind of dovetails with the other issue, which is adherence. The initial ones, you're injecting those or using an auto-injector every week. We now have some oral options from both Novo and Lilly, but those require daily administration. And then aside from just keeping up with a medication regimen, you have side effects and things like that, potentially causing some people to fall off the correct regimen that they've been prescribed. So I think Amgen is really positioning Meritide as potentially solving some of these pitfalls or remaining unmet needs when we're looking at the current crop of obesity and even diabetes medicines when we're thinking about GLP-1s. And that honestly held true for a lot of the other sort of big name pharma companies that I spoke to. So just to kind of really quickly run through without maybe going through all the explicit data, but we also spoke to AstraZeneca. I met with executives at Roche, Beringer Ingelheim as well in connection with the conference, and they all have pretty late stage assets in obesity. And admittedly, if we're kind of looking across the board, none of these really hit the level of weight loss that we're seeing with something like Roto-Trutide, or even if we're thinking about Novo's next-gen asset, Kagrissema, both of those kind of seem to be leading these other companies that are getting in a bit later. But in turn, many of those companies are talking about sort of the more nuanced benefits their drugs can provide, as well as potential perks when it comes to things like convenience or tolerability. We'll look at Beringer-Ingelheim, for instance, for their asset. They're talking a lot about the ability of their candidate to specifically help patients lose visceral fat, this being kind of the fat that surrounds the organs, which is widely believed to be the kind that is sort of most harmful to patients and also plays into that debate about whether current GLP-1s are causing patients to lose too much lean mass, which would include things like muscle mass. So, you know, I think interesting stuff. A lot of folks want to seem like they have the next big asset, but I think the two leaders right now, Nova and Elise, still kind of seem to be maintaining that leadership on the R&D front. But in turn, we have a whole lot of jockeying from companies about what the evolving weight loss landscape might look like and how maybe a greater breadth of treatments could kind of pinpoint different patient preferences. Well, of course, beyond all your data reporting at the event, you managed to snag a huge interview with the head of the diabetes giant, that is Nobu Nordisk. You had a sit-down interview with their CEO, Michael Dustar. And this turned into a really fantastic story that gave us a real inside look at a major CEO transition during such a key year for Nobu. Honestly, tell me everything. What is he like? What was it like to talk to him? What did you guys talk about? Yeah, this was awesome. I mean, no doubt for me personally, it was the highlight. And I had said earlier that the conference itself was kind of a culmination of a lot of the GLP-1 coverage that we've done at Fierce and also my work personally kind of jumping onto that beat over time. And Nova is a company that I've worked closely with. I had spoken to their previous CEO, Lars, and their U.S. headquarters in New Jersey a number of years back when the situation was quite different and they were still kind of on their own. Lily was still sort of new in the weight loss scene. But this was one that came together kind of last minute. Novo obviously was very busy, but they seemed like they really wanted to get us some time in front of their CEO. And I'm really happy they did because I thought he was quite personal and really just eager to talk. And I think if you check out the story, which I would encourage everyone to do, I think we honestly got quite a bit out of it, despite the fact that with any meeting at ADA, there's a kind of rapid fire nature to the proceedings as people are moving in and out of various appointments But first of all I think his pictures on the website do him justice Zoe I was not caught off guard This was the mic I was expecting to see but really just a really friendly guy And I think a big part of our conversation was kind of just vouching for this confidence in Novo positioning now and what the company can accomplish and also sort of what the company identity means in light of sort of the immense public attention that the weight loss field has generated And the fact that we're kind of, I think, constantly and inherently doing these comparisons between Novo and Eli Lilly as much of this conversation today has illustrated. But I mean, I think overall, Mike was really just, I think, trying to vouch for the fact that he feels a lot more confident in the position that Novo is today. And a big part of that, and Zoe, I think you maybe have a specific question on this, is the really just kind of staggering launch of the company's oral obesity medication earlier this year. And we've talked a lot in our writing about how Lilly has kind of superseded Novo in terms of market share for obesity in the US. But Novo did, as it had with Wagovi, beat Lilly to the punch in terms of launching its oral weight loss medication. And really right now, at least in terms of the prescription information that we've been able to track, it seems like the Wagovi pill is just doing gangbusters as Lilly's pill, which is called Foundeo, kind of continues to ramp up. Yeah, I mean, he announced right or the company recently announced right before you spoke with him that the pill had surpassed more than 3 million prescriptions, which, of course, and of course, like you said, we've been tracking this on our GLP one tracker, but definitely plays into what he was saying in your interview about how ADA is now more about obesity than diabetes. It seems is that something that you observed as well? Yeah, I mean, so Duster said that just kind of, I mean, I think his perspective too, and really quickly to just go back to this was that it's kind of humbling for Novo Nordisk to see so much of its efforts validated at the conference, its pursuit of GLP-1 agonism as a means to leave to weight loss. So many companies are doing this now. But yeah, Duster did say that it's kind of surprising. It is the American Diabetes Association scientific sessions. But obviously, what is driving so much of the attention now is obesity. And obviously, these conditions are directly interrelated. Oftentimes, people will have both. But really, it is sort of this weight loss component and looking at obesity that seems to have dominated a lot of the attention. And this is something that I heard from others as well. I'd also spoken to a smaller company called iBio. And we recently put up a story on Fierce Biotech covering my interview with their CEO and their chief financial officer. But Zoe, I don't know if you read that one. It's a kind of a strange story. They were originally trying to do CDMO stuff with plant-based manufacturing, kind of how Medicago was doing during the COVID pandemic. And then when Medicago went under, they decided that was not going to be a sustainable business. So they ended up licensing this AI-enabled drug discovery platform and have kind of pivoted into metabolic medicine. My point is that just in kind of having this long conversation with the CEO who'd been at many other big-name pharmas in his time, he commented on the fact that maybe like a decade ago, the conference ADA had kind of died down as SG2 inhibitors had sort of become the standard in treatment of diabetes. And this is also something that I heard from Amgen when I was talking to their CMO, that there had kind of just been this benchmark established in diabetes care that was hard to top. And so there really wasn't this huge excitement around innovation and what was next. And so things kind of stagnated. And it wasn't to say that like treatment necessarily was stagnating in the real world, but there just wasn't as much excitement, I think, on the R&D side of things. And now everything that's happening with GLP ones and beyond, and just sort of this Incretan medicine boom is really unlocking a new wave of excitement. And I think I can say with confidence that we will be back next year. And I will be requesting that we send a second writer as well, because this is obviously turned into a conference that's kind of hard to miss. Absolutely. And yeah, this definitely speaks to where we are today with all that. And that's especially interesting, given the context of your previous interview with their former CEO, Lars. I mean, like you said, I'm sure they're in such a different place back then. So I'm sure it's very interesting to compare the two. Yeah. And I think to note too, Lars at the time was really kind of hitting on the same point that many companies were, which is it's not just about the weight loss. I mean, even back then there was a big focus on what else semaglutide could potentially tackle, whether that was comorbidities of obesity or even other kind of far afield indications for looking at things like Alzheimer's disease or like substance use disorder, things like that. But just really interesting stuff. And I mean, just super fun to watch this this play out. And like I said, I think it's going to be fun to keep tabs on this conference moving forward. Well, you heard it here. First, everyone, we will be back at ADA next year, hopefully with another writer. But thank you so much for joining me today, Fraser, to go over all of this. Is there any final thoughts about the conference this year? Yeah, big news. I got the second issue of the Gluconaut comic book that Insulet is doing in combination with Marvel for their Omnipod insulin delivery device. Our marketing writer Ben had covered this previously. The first one is called Diasonic Sound of Strength about an Omnipod wearing superhero. And there was a sneak preview issue that was put out at the conference. I'm not sure if I'm allowed to talk about what it is, but if you guys are fans of this Omnipod the comic book, then keep an eye out because I have been having fun reading it. Thanks, Zoe. This was a great conference. And like I said, I think we're really excited to continue to cover ADA in the future as the space continues to evolve. That's it for The Top Line. I'm your host, Ayla Ellison. You can find out more about this topic in our show notes at fiercebiotech.com. Look for podcasts. And that's the bottom line from The Top Line. Thank you.
